Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134524
Status:
UNKNOWN
Last Update Posted:
2007-07-10
First Post:
2005-08-22
Brief Title:
The Effects of the Magnetic Molecular Energizer MME on Diabetic Peripheral Neuropathy
Sponsor:
Advanced Magnetic Research Institute International
Organization:
Advanced Magnetic Research Institute International
Study Overview
Official Title:
A Randomized Sham-Controlled Clinical Study to Evaluate The Effect of the Magnetic Molecular Energizer MME on Diabetic Peripheral Neuropathy
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is intended to demonstrate that exposure to a high intensity DC electromagnetic field as supplied by the investigational device known as the Molecular Magnetic Energizer MME will create a clinically meaningful improvement in pain and nerve dysfunction in the feet of patients with diabetic peripheral neuropathy DPN
Detailed Description:
Diabetic peripheral neuropathy DPN affects up to 12 of diabetics both type I and II It contributes to limb amputation and can cause painful symptoms which are difficult to treat Application of a high intensity DC electromagnetic field as supplied by the investigational device the Magnetic Molecular Energizer MME has shown in a pilot study with participants having DPN in their feet to have created significant improvement in painful symptoms and improved measures of neurologic function in 7 of 10 participants This study will enroll participants and evaluate them at baseline with regard to pain levels nerve function and quality of life They will then be randomized to receive 120 hr exposure to either active MME procedure or sham procedure Following the 120 hrs the participants will then receive the same evaluation for pain level nerve function and quality of life These evaluations will be repeated a final time 6 months following The participants will be blinded to whether they receive the active or sham procedure
The MME procedure consists of laying on a bed with the feet lying in the space between two large electromagnetic coils which when activated produce a DC magnetic field measuring 5000 gauss The participants will lay on the bed with feet in the magnetic field for 8 to 12 hours a day for 10 to 16 days in succession Breaks are allowed and no restraints are required The procedure may be done at night so that participants may sleep
Pain assessment will be done by self assessment using rating with the Visual Analogue Scale
Neurologic function will be assessed with Cutaneous Perception Threshold testing using the Neurometer a commercially available FDA approved device
Quality of life assessment will be by the Neuropathy Specific Quality of Life Questionnaire
The MME procedure consists of laying on a bed with the feet lying in the space between two large electromagnetic coils which when activated produce a DC magnetic field measuring 5000 gauss The participants will lay on the bed with feet in the magnetic field for 8 to 12 hours a day for 10 to 16 days in succession Breaks are allowed and no restraints are required The procedure may be done at night so that participants may sleep
Pain assessment will be done by self assessment using rating with the Visual Analogue Scale
Neurologic function will be assessed with Cutaneous Perception Threshold testing using the Neurometer a commercially available FDA approved device
Quality of life assessment will be by the Neuropathy Specific Quality of Life Questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None